Ultrasound laboratory information management system and method

ABSTRACT

A multifunctional information management system that integrates a plurality of modules, each of the modules being interfaced via a relational database. The integrated system manages a large volume of business, data, and image information and is capable of being accessed/organized via the Internet. One embodiment of the multifunctional information management system is an ultrasound laboratory information management system (ULIMS) for a medical ultrasound imaging and hemodynamic laboratory, e.g., an echocardiographic or comparable medical laboratory environment, incorporating a multifunctional management system. The ULIMS includes: 1) Scheduling and Workflow Modules; 2) Patient Information and Demographics Modules; 3) Billing Modules; 4) Procedure Information and Referral Diagnosis Modules; and 5) Measurement, Templates and Calculations Modules; 6) Final Impressions and Interpretation Modules; 7) Procedure Report Modules; 8) Serial Studies Module; 9) Research Protocols Module; 10) User Interface and Services Modules; 11) Web Based Modules; 12) Unique Reports Modules; 13) Database Modules; 14) Systems Administration Modules; 15) Security, Privacy and User Configuration Modules; 16) Image Modules; 17) Systems and Technical Support Modules; and 18) Knowledge Base Modules.

FIELD OF THE INVENTION

[0001] The present invention relates in general to an informationmanagement system and method, and more particularly, to an ultrasoundlaboratory information management system and method.

BACKGROUND OF THE INVENTION

[0002] Medical ultrasound is currently used throughout the practice ofmodem medicine and one of the most commonly performed examinations.Medical ultrasound is a very safe energy source with no known toxiceffects under normal use circumstances. A medical ultrasound laboratorysupports a diverse number of functions formally performed by moreinvasive technologies, e.g., imaging, functional cardiovascularassessment, Doppler hemodynamics, and visualization of blood flow, etc.Ultrasound can be formulated into numerous sizes and shapes in order toaccommodate specific applications, e.g., transesophageal echo,intravascular echo, handheld, transvaginal echo, etc. Meanwhile, newinnovations, which include multidimensional imaging, miniaturizeddevices, digital imaging, intravascular and other invasive devices, andthe use of tracer contrast agents, have been developed. Therapeuticultrasound and parametric imaging are also being developed. Today, alarge amount of relevant clinical, research and education informationcan be acquired, collated, stored and transmitted. These diverseapplications and functionality, in conjunction with the evolution ofcomputer technology, create a need to increase the efficiency ofinformation management within the field of medical ultrasound.

[0003] In order to support numerous functions of a modem ultrasoundlaboratory, a robust, state-of-the-art information management system isneeded. Attempts to develop management systems for medical ultrasoundfacilities have thus far been fraught with disappointing results. Mostcurrent systems are immature and do not bring to bear the full resourcesof a large clinical laboratory system, such as the NoninvasiveUltrasound Imaging and Hemodynamic Laboratory developed by Mayo Clinicin Rochester, Minn.

[0004] There currently is need for an information management systemcapable of handling diverse ultrasound resources and processes, tocollate and database these into a sophisticated and unified application.

[0005] It is with respect to these or other considerations that thepresent invention has been developed.

SUMMARY OF THE INVENTION

[0006] In accordance with this invention, the above and other problemswere solved by providing a multifunctional information management systemthat integrates a plurality of modules, each of the modules beinginterfaced via a relational database. The integrated system manages alarge volume of functional, anatomic and work related data, as well asimage information. The system is capable of being accessed and organizedvia an Internet interface.

[0007] In one embodiment, the present invention provides an integratedultrasound laboratory information management system suitable for amedical cardiovascular ultrasound imaging and hemodynamic laboratory, oran echocardiographic or comparable medical ultrasound laboratoryenvironment. The system is capable of supporting patient management,data collection, and final report preparation. The system has theflexibility to support scaleable input of data from multiple sources inmultiple locations via wired and wireless connections. The system isalso dynamic and can easily be enhanced to grow with a laboratory'scapacity and configuration. A final report of the system supportsgraphics that are accessed via an Internet web browser operating system.

[0008] An information management system in accordance with theprinciples of the present invention is designed and built to fulfill theneeds of diverse type of ultrasound laboratory. The system can bedistributed to a diverse number of users with varied needs. The systemis capable of fulfilling the needs of stand-alone facilities as well asoutreach services. Further, the system is scaleable to accommodateprojected increase in volume, capacity, personnel, and space.Furthermore, the system is built in components, which can be removed,modified, and/or replaced as desired. Moreover, the system is extensibleand does accommodate data, graphic, and image management technology.

[0009] Still in one embodiment, a medical ultrasound laboratoryinformation management system is integrated mainly from three parts: abusiness management part, an ultrasound data management part, and anultrasound image management part. The business management part of thesystem manages all aspects from running a small clinic to a very largemedical enterprise. Within a medical ultrasound environment, thebusiness management part generally refers to documenting examencounters, patient demographics, accounting, scheduling, billing,productivity measures, clinical accountability, etc. Immediatelyconnected to these functions are the systems related to accounting, suchas a third party billing, coding, documentation, reimbursement, etc.Other related connections include remote access to extended practicesand locations, national and international access and communications,etc.

[0010] Further in one embodiment, the ultrasound data management part ofthe system includes acquisition, collation, and reporting of acquiredalphanumeric information, such as measurements, hemodynamics, function,flow calculations, derived information, impressions, text descriptors,etc. This is a complex and ever changing aspect of clinical ultrasoundexaminations. The presentation of data can be tabular, textural,graphic, or pictorial. Further, the presentation of data may continue toevolve such that an information management system of the presentinvention is designed to accommodate and support a dynamic process. Thedata is typically used for clinical decision-making. Also, the system ofthe present invention allows the data to be used for fields such aseducation, research, treatment, and therapeutics, etc. Accordingly, thedata or information in the information management system of the presentinvention are collated as well as retrieved in a systematic manner.

[0011] Further incorporated into the ultrasound data management part ofthe system is a knowledge based artificial intelligence.

[0012] The ultrasound image management part of the system accommodateslarge-sized documents, such as graphics, still and cinematic pictures,digital documents, parametric information, etc. A large-sized digitaldocument, for example, an image or graphic document that is displayedwith a high frame rate (e.g., 200 to 300 images frames per second), ismanaged by the system of the present invention. All image informationare collated as well as retrieved in a systematic manner and treatedsimilar to the other data. The data volume in the image managementcomponent is significantly greater than the data volume in the previoustwo functions.

[0013] Yet in one embodiment, all information provided by the businessmanagement part, the ultrasound data management part, and the ultrasoundimage management part are integrated into a single informationmanagement system.

[0014] These and various other advantages and features of novelty whichcharacterize the invention are pointed out with particularity in theclaims annexed hereto and form a part hereof. However, for a betterunderstanding of the invention, its advantages, and the objects obtainedby its use, reference should be made to the drawings which form afurther part hereof, and to accompanying descriptive matter, in whichthere are illustrated and described specific examples of an apparatus inaccordance with the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Referring now to the drawings in which like reference numbersrepresent corresponding parts throughout:

[0016]FIG. 1 illustrates an operational environment for a laboratoryinformation management system in accordance with the present invention.

[0017]FIG. 2 illustrates an operational environment for a centralinstallation of a laboratory information management system in accordancewith the present invention.

[0018]FIG. 3 illustrates an operational environment for a remoteinstallation of a laboratory information management system in accordancewith the present invention, the remote installation being linked to thecentral installation of FIG. 2 via a wired connection.

[0019]FIG. 4 illustrates an operational environment for a remoteinstallation of a laboratory information management system in accordancewith the present invention, the remote installation being linked to thecentral installation of FIG. 2 via a wireless connection.

[0020]FIGS. 5 and 5A through 5X illustrate a database table diagram fora laboratory information management system in accordance with theprinciples of the present invention. FIG. 5 illustrates the overalltable with a drawing location reference grid comprising 24 tiles. Eachtile is labeled 5A through 5X and corresponds to the similarly numberedFIGS. 5A through 5X.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[0021] The present invention discloses a multifunctional informationmanagement system that integrates a plurality of modules, each of themodules being interfaced via a relational database. The integratedsystem manages a large volume of business, data, and image informationand is capable of being accessed/organized via the Internet.

[0022] As an example, the present invention provides an integratedultrasound laboratory information management system suitable for amedical cardiovascular ultrasound imaging and hemodynamic laboratory, oran echocardiographic or comparable medical laboratory environment. Thesystem supports patient management, data collection, and final reportpreparation and has the flexibility to support scaleable input of datafrom multiple sources. The system is dynamic and can easily be enhancedto grow with a laboratory's capacity and configuration. A final reportof the system supports graphics that are accessed via an Internet webbrowser operating system.

[0023] The ultrasound laboratory information management system inaccordance with the principles of the present invention is integratedmainly from three parts: a business management part, an ultrasound datamanagement part, and an ultrasound image management part. The integratedsystem is capable of being used for a medical cardiovascular ultrasoundimaging and hemodynamic laboratory (i.e., echocardiographic orcomparable medical laboratory environment). In one embodiment, theintegrated system includes a plurality of modules: 1) Scheduling andWorkflow Module; 2) Patient Information and Demographics Module; 3)Billing Module; 4) Procedure Information and Referral Diagnosis Module;and 5) Measurement, Template, and Calculation Module; 6) FinalImpression and Interpretation Module; 7) Procedure Report Module; 8)Serial Study Module; 9) Research Protocol Module; 10) User Interface andService Module; 11) Web Based Module; 12) Unique Reports Module; 13)Database Module; 14) Systems Administration Module; 15) Security andUser Conation Module; 16) Image Module; 17) System and Technical SupportModule; and 18) Knowledge Base Module.

[0024] The advantages of the present invention are that the system isrobust, template-driven, and Internet-accessible. The system hasincreased its reporting functionalities and provides guided billingfunctionality. In addition, the system provides outreach practicesupport and allows serial study of the measured data and information.Further, the system encompasses business management, data management,and image management.

[0025] The above-described modules of the system are described in detailas follows:

[0026] 1) Scheduling and Workflow Module

[0027] The scheduling and workflow module of the system tracks a patientfrom initial scheduling of an appointment, through checkin, procedure,and checkout, i.e., discharge. The module may also contain therequirements for physicians, sonographers, and support staff to reviewworkflow or workloops. It is appreciated that the system may receiveinformation from other scheduling systems with an appropriate interface.

[0028] The operation of the scheduling and workflow module starts with apatient arriving at a specific echocardiography lab location for aprocedure. The patient's visit is completed when the patient isdischarged. There is a possibility that a patient may have more than onevisit in a day, and that each visit may have multiple proceduresscheduled. There may also be emergency situations where all theinformation needed to “check-in” a patient may be added later.

[0029] One step of the operation is to identify a patient's schedule ona given visit/day. This can be by a patient name, identification number,or other relevant information such as ID tag, time, lab location,referring physician, appointment type, and referral diagnosis, etc.Patient status, report status, assigned personnel, comments, and/orhospital information can then be viewed as they become available. Thestyle of a scheduling display and/or variations of the schedulingdisplay are dependent on the user's preference and may be used at thedesk or checkin location for a lab.

[0030] Another step of the operation is to filter out certain viewedinformation from a scheduling display as a user may be only authorizedto view certain information of the scheduling display. This filteringfeature allows a user to readily change appointment dates and locations,appointment types, report status, patient status, and assignedpersonnel, etc. Further, a report filter allows one to look at all ofthe variables/fields or a combination of the available variables/fields.It is appreciated that additional report filter may be used to allowviewing all appointments or only filled appointments within the scope ofthe present invention, and that default views or templates may beconfigured by a user or a system administrator.

[0031] A further step of the operation is to provide a display thatshows room status information at any point in time. The room status viewillustrates that the data or information is arranged in such a way thatit can be accessed by the other users, like viewing an “airport displayboard”. In one embodiment, the display shows all rooms for a location.If a patient's record reflects “Roomed” or “Waiting Review”, then thepatient is reflected on the display.

[0032] In the scheduling and workflow module, all data recorded may havesystem-generated time stamps, as a patient proceeds through the visitfrom arrival to discharge.

[0033] The patients' appointments can be made at a central appointmentdesk (CAD) system and communicated to the other modules of the systemthrough an external interface. It is also appreciated that patients'appointments can be made remotely. When an appointment is made in aremote site, the appointment is sent to the system. The system thenmatches the location, time, and appointment type and fills in theappropriate slot on the scheduling and workflow module. If the systemdoes not find an appropriate slot to fill the appointment, then thesystem forces to fill in the appointment on the schedule and flag theappointment as “a forced appointment”.

[0034] Also, a scheduled appointment can be deleted via the system. Itis appreciated that the scheduled appointment can be deleted via aseparate or remote appointment system. Such deletion is communicated tothe system to further modify the scheduling and workflow module.

[0035] An additional step of the operation is to capture patient statusinformation, such as the beginning time, current state, etc., throughoutthe visit. The step may also capture report status information, such asthe beginning time, current state, etc., throughout the visit.

[0036] The changes made in the system can be automatically triggered ormanually triggered, appointments can be made for any appointment type,and the module includes a flexibility to override most of the predefinedfields. It is also appreciated that all appointments within a userspecified time frame for an individual patient can be viewed. It isfurther appreciated that the scheduling and workflow module has thecapability of moving appointments around and the capability of searchingfor appointments by person, referring physician, date, time, and status.Furthermore, it is appreciated that the scheduling and workflow modulehas the capability of searching for open appointments by a date range,location, and an appointment type. If a specific personnel is requested,the scheduling and workflow module may assign the personnel at thescheduling time. The schedule display highlights any specific personnelassigned to a patient that the status of the patient is less thanroomed.

[0037] The scheduling and workflow module allows to identifysonographers, ECG tech and Echo staff availability by location. This canbe accomplished by “check in” and “check out” statuses that are changedon the display. The scheduling and workflow module may also providecapability to view and monitor the unfilled capacity by location,appointment type, date, and day of week, etc. For example, the modulecreates an assignment list of available sonographers, physicians, andadditional personnel as needed. This list is used to assign a specificpersonnel to a patient at check-in or at any other time during a medicalprocedure. Also, a patient status is changed manually by a system useror automatically, when applicable. Each change in status may create asystem-generated time stamp. Thus, the module provides a dynamic displayof patient status information, distinguishes in-patients fromout-patients, allows to cancel a scheduled visit and make availablehistory of cancel or rescheduled appointments, provides views forcancelled or rescheduled appointments, and allows the patient data to besearchable by a clinic number or patient number.

[0038] Also, the module provides capability of checking a patient'sstatus on an individual basis and any available details, such astimestamp, length of time in status. For example, the module may providethe “No Show” review list and/or “Master Review List” by day and theability to change their status on the display. The default view maylooks like “Scheduled/Check In” view but in addition containsappointment date. The display may contain only patients with a reportstatus of “Open” through “Report Complete”. The patients remain on thislist until they are in their final status. Filtering is available forall other statuses except scheduled, canceled, no show, and final.Accordingly, the module allows for a “Review List” but filtered bypersonnel. The default for the “Review List” may be all available reportstatuses and a logon user. A filter is established for users of thesystem so they only view certain locations/status of patients.

[0039] The module also monitors and assigns equipment available for labusage. An equipment list is provided for such function. In oneembodiment, a table is established to associate rooms with equipment sowhen rooms are assigned to patients, the equipment assignment takesplace automatically. This equipment, by serial number and otheridentifier, would be kept with a record in the module. Accordingly, themodule displays a location for each equipment. For example, if anelectronic environment device (EED) is located outside a group of rooms,the module would provide default views of the patient studies currentlyin progress in these rooms. The module also provides capability for labstatus view. For example, the module monitors, at any point during theday, a status of patients waiting, scheduled, or completed.

[0040] 2) Patient Information and Demographics Module

[0041] The patient information and demographics module of the system isincorporated into the process of checking a patient in. It also includesdemographic data and coordiantes where that type of information is usedor displayed. Some of this information is also described in thedescription of the scheduling and workflow module, above.

[0042] In an operation, as soon as a patient's visit begins, data areaccumulated specific to the patient and procedure. Some of the data areavailable from an external system, such as a central review device(CRD). Additional data are recorded on the patient through the visitduration. An example of this data is hemodynamics, such as bloodpressure, weight, height, etc.

[0043] The operation continues with accumulating/recording patient'sregistration and check-in information. The information collected atcheck-in is, for example, height, weight, BSA, BMI, birth date, sex,gestation age (if applicable), and fasting information, etc. Some of theinformation may be pre-loaded from the system through a user interface.When patient check-in is complete, a time stamp is taken, and thepatient status is changed to “Check In”. The patient information anddemographics module keeps track of all item changed in a “change log”and shows demographic data on multiple views. For example, in outreach,the patient information and demographics module provides a place toinput maiden name and previous married names of a patient, additionalcomments, etc. Based on the information in the module, a quicknavigation to access information from a schedule can be made. It isappreciated that demographic data collection views may be different foroutreach than in a central lab.

[0044] 3) Billing Module

[0045] The billing module of the system accumulates and sendsinformation to a remote billing system.

[0046] In an operation, for each procedure performed, the billing modulecaptures all billable components and associates all billable entrieswith a specific patient, diagnosis, visit, and ordering physician. Forexample, the billing module creates an association between billingdiagnoses and billing entries. This association validates thatappropriate items are charged for the procedure. For all professionalservices provided, the billing module allows for the distinction betweendifferent classifications of procedures and the respective billingrates. Examples may include the classifications of “limited”, “nocharge”, “complex”, “grant”, and “research account”, etc. Accordingly,the billing module provides a unique list of billing items for eachdistinct billing classification of procedures and provides a reportingmechanism that communicates when procedures are completed but a billingrecord has not yet been sent.

[0047] Also, the billing module provides a monthly/daily summary ofbilling charges organized by day, site, and type of charge, proceduretype. In one example, the billing module may provide a report ofaccounts of patients who have completed the procedure. In anotherexample, the billing module provides a summary of charges year-to-date(YTD). Further, the billing module provides a clue of billing items,referral diagnoses, measurement performed, procedure type, and procedurecomponents, etc. It is appreciated that the billing items, referraldiagnoses, measurement performed, procedure type, and procedurecomponents, can be coded or bar-coded for searching and other functions.

[0048] 4) Procedure Information and Referral Diagnoses Module

[0049] A procedure or study is the primary designation for the variousactivities surrounding a patient visit. A lab may perform multipledistinct procedures encompassing, for example, the gamut from pediatricto stress echo to intra-operative procedures. A physician referraldiagnosis is provided whenever an appointment is created. It isgenerally a text that gives one as much information as possible aboutthe reason the patient is scheduled for a study. The module may replacethe text by a “coded” referral diagnosis. The “coded” referral diagnosisis determined by a sonographer early in a patient visit. This diagnosisthen appears on a final report and is used for any retrospectiveretrieval. Billing referral diagnoses can be suggested based on the“coded” referral diagnoses. Also, billing referral diagnoses can bedesignated at the end of the patient visit based on the proceduresperformed, equipment used, and other practice-related factors. Thesediagnoses correspond to valid charge codes on the billing system.

[0050] As an example, when a patient is roomed, the system assignspersonnel if not already assigned. This allows for easy navigation toassign personnel whenever they are available and allows for assignmentof roles to a study when a specific individual is not known.

[0051] Also, procedure types are assigned to each study. The proceduretypes can be defaulted initially by an appointment type. For example, anappointment type of “EXERCI” stands for the procedure type of “ExerciseStress”. By selecting an appropriate procedure type, the module usesthis information to guide one to the best templates and tabs availablein the system. For example, if a procedure type choice istransesophageal echo, then a tab is available to collect sedationinformation.

[0052] It is appreciated that some procedure types need furthersub-division in order to guide a user to appropriate templates. Anexample of this is Exercise Stress procedure type. An Exercise Stressprocedure type can be further divided into treadmill, bicycle, andinterpretation only.

[0053] Procedure types are also associated with procedure components.Procedure components are descriptions of what is actually done during astudy. For example, the procedure type of basic adult echo generatesprocedure components of 2D, Mmode, and Color Doppler, etc. There isstill an outstanding issue of whether the procedure components areneeded for a final report. The system also allows multiple procedurecomponents to be selected and assigned during a single visit if needed.The system determines initial required medical history information basedon referring diagnoses and procedure component and supports the use oftemplates for organizing measurements into predefined groups.Accordingly, the system allows the ability to select or use anytemplate. The system can also determine the initial required medicalhistory information based on referring diagnosis and procedure type.

[0054] In operating the Procedure Information and Referral DiagnosesModule, time stamps are collected during a procedure that recordscheck-in, roomed, and discharge times, and preliminary impressions orother comments are recorded from sonographers and other cliniciansthroughout the patient visit whenever needed. The user may designatewhich of these should appear on a procedure report. Clinician commentsand dictated physician comments should be optionally checked forspelling errors.

[0055] As an example, an appointment type of “Research XXX” indicatesthat this is for a specific set of procedure types. Once this is chosen,very specific templates for the studies can be selected. Researchtemplates must have every data item as a required field. This isdifferent from other study templates. Based on this, a requirement ofthe templates is to vary whether fields are required or optional.

[0056] Also, based on the capabilities of the measurement andcalculation database, there may be an additional need to store specific“stress” information outside of the configurable database. Differentprotocols may require different templates and different data items.

[0057] The module also provides access to sedation template for anyprocedure type that may require sedation. Data items needed for printedreport are a subset of the standard data recorded on all patients, plussignificant other data. A lot of this data is a free form text that doesnot easily fit into the measurement database.

[0058] 5) Measurements, Templates, and Calculations Module

[0059] Measurements are the core data components that provide theability to effectively diagnose patient health. A lab, such as an echolab, operates in a dynamic environment due to advances in medicalknowledge and diagnostic instrument capabilities. The present system hasthe ability to define new measurements and incorporate them intoprocedures. With the number of measurements and calculationpossibilities, it is important to be able to dynamically organize dataitems according to the type of study being performed. The use oftemplates (pre-organized data) facilitates the quickest data entrypossible. The system also organizes the data for analysis that may bedifferent than the organization necessary for input. Templatesfacilitate this as well. The module allows the definition of customnumeric measurements and depends on the configurable numericmeasurements for all procedure measurement data acquisition. Thesemeasurements include echo-specific and other clinical measurements. Eachmeasurement may ask for sufficient information to describe the data typeand precision, anatomical section, valid modalities, display andsymbolic labels, units of measure, timing, and measurement name/type.Some notion of versioning may be required to ensure properinterpretation and retrospective aggregation of “modified” measurements.

[0060] The module also allows the definition of qualitativemeasurements. Qualitative measurements provide the ability to makesubjective assessments or general comments regarding a particularanatomical area or other miscellaneous procedure aspect. The most basictype of qualitative measurement is a free form text string. Otherqualitative measurements may make use of selection lists. This lattertype may be used in calculated measurement expressions, primarily as thetest condition in “If” tests.

[0061] Further, the module allows the definition and validation ofcalculated measurements. Calculated measurements are the product ofpreviously defined numerical measurements, constants, and logicselection based on selection list-based qualitative measurements.Formulas are created using the measurement symbolic names andmathematical operators. Certain patient/visit attributes, such as heightand weight, need to be available to a calculation engine. Editing anyentered measurements result in re-computation of a calculated result.Descriptions of measurements may be available via a help function key.Descriptive information may also include externally created text as wellas a symbolic representation of calculations used for calculatedmeasurements. The module allows the definition of measurement templatesto facilitate date entry. Measurement template also allows the user toorganize measurements into groups based on anatomy, modality, or otherparadigms chosen by the lab. For example, a stress protocol template canbe included for capturing time-series measurement values. Stressprotocols identify predetermined control variables applied andmeasurements collected overtime during a stress procedure. In anexercise stress echo, a treadmill grade and speed are control variables,while heart rate and blood pressure are acquired measurements. In apharmacological stress procedure, medication and dosage may replacegrade and speed. The protocol also defines the time interval (orpossibly another event) between stages.

[0062] The module also supports the creation of predefined stressprotocols that provide the stages or steps of stress echo procedures.Typically, this involves specifying the “control variables” and timeintervals. Automatically generated procedure measurement entry screensare based on template content. Templates may require additionalinformation to help in screen layout. Such information may includegrouping indicators and orientation. The order of measurements in atemplate helps determine ordering on the entry screens. An example wouldbe a stenosis indicator on a template that, when pushed, would changethe template or template content.

[0063] The module further supports capability of report templates. Thesetemplates are used to produce a framework or roadmap for a report, e.g.an Echo report. The template supplies the interpretation requirementsand measurements. Additional items can be added adhoc to the echo reportas it is being built.

[0064] In addition, the module supports the storage, retrieval, andcalculations of normal ranges for measurements. Normals result from datacollection and analysis over time. Demographic categorization is theprimary method of differentiating normals across a population. Forexample, all males over 20 may share normals for a particular set ofmeasurements. The approach to implementing normals supports the abilityto stratify a patient and return values from database tables and/orcalculations, and to add new tables and algorithms for normalscomputation and lookup without modifying the primary application.

[0065] As research proceeds or new prosthetic devices are brought tomarket, the need arises to extend the existing normals models. Thepresent system provides a solution by creating normals models andreturning values that are independent or well abstracted from theprimary application. The system may utilize the following tables:Feignbaum tables for adults without BSA measurement; Gardin tables foradults with BSA measurement; Henry tables for pediatric patients;Prosthetic valve normal ranges —from manufacturer; and Diastolicfunction normal ranges. The module allows to visually flag anymeasurements falling outside normal ranges and provides ability toorganize measurements by normals and those outside the normal range.

[0066] Furthermore, the module provides ability/extensibility todynamically build templates based on an image and measurements recordedon the image. A specific measurement is only required to be input once,regardless of any change in templates, procedure type, or hemodynamicdata. The system also accommodates enhancements necessary for futureassociation of measurements to data acquired from multi-vendorultrasound equipment via interfaces, such as the Digital Imaging andCommunications in Medicine (DICOM) interface. The measurements acceptmore than one input value, resulting in an average for the measurement.The system stores and displays all entered data and allow them to bereedited, resulting in a re-computation of the average. An averagedresult can be flagged visually on entry screens and reports.

[0067] Moreover, measurements are retrievable via a relational databasequery tools. Due to the desire for a measurement system to beconfigurable, the database tables used for storing measurements may notconform with the traditional notion of a database field corresponding toeach measurement. Rather, a name/value approach is used, which wouldrequire intermediate processing in order to create optimal tables andqueries for research purposes. Such intermediate processing may probablyoccur after hours, which in turn would minimize performance impact ofqueries on a production database. Measurement entry and storage allowfor entering multiple sets of measurements at user-defined points duringthe procedures.

[0068] Procedures, such as respiratory comparisons, require that two ormore sets of measurements be obtained. The module provides defaultstages for these procedure types, such as prestress/poststress, as wellas allowing for new measurement sets to be created and labeled asneeded.

[0069] The module also supports a graphic-based annotation method forwall motion data interpretation and scoring. The graphic display mayinclude multiple cross-sectional views. The views may includeperisternal short axis, apical 4 chamber; apical long axis; apical 2chamber; and peristernal long axis.

[0070] The module may also support a graphic-based annotation method forthoracic aorta measurements. The data generated from the measurementssupports a thoracic aorta serial study.

[0071] 6) Final Impressions and Interpretations Module

[0072] The interpretation of a clinical patient visit is summarized viafinal impressions. Physicians create final impressions to communicateclinical assessments and recommendations to the patient and othercaregivers associated with the patient's current and ongoing care andtreatment. The physician final impressions are an important component ofa patient's report, such as an echo report. Sonographers createindependent “coded” final impressions to aid in retrospective retrievalof studies based on standardized phrases and terms. These coded finalimpressions are not included in the procedure report. The finalimpressions and interpretations module provides a free form comment areathat the consultant or sonographer can dictate or type comments that aresignificant about the study that cannot be captured easily by the finalimpression statements.

[0073] In the measurement capture and analysis templates, the moduleprovides ability to access final impressions statements. This requiresthat specific templates or measurements have a logical relationship tofinal impression statements. For example, an ejection fractionmeasurement may have a statement that states an observation about theejection fraction and puts in the measurement result into the statement.Another statement may require that a measurement be recognized as normaland automatically generate a statement that describes normal function.

[0074] Different procedure types display different report templates.These report templates have categories of statements that must be codedin order for the report to be complete. They help facilitatecompleteness and consistency. These coded statements generate text orbullet items for an interpretation section of the report, e.g. an echoreport. In addition, these coded statements are used for retrospectivestudies.

[0075] The report interpretation section can be dynamically generated bythe measurements, sonographer coding, and/or consultant coding. Themodule allows to extract or mark any coded item to be also shown as afinal impression. A coding mechanism may be required to allow theassembly of final impression phrases with corresponding numericrepresentations that may be accessed for retrospective research viarelational database access. The module also has the capabilities whichinclude prompted numeric values and ranges, singular/plural modifiers,test substitution, ordered parameters, modifiers, report or entry formsuppression, free-form text entry, date/time prompting, and linking ofphrases into paragraphs, etc.

[0076] 7) Procedure Report Module

[0077] As soon as a patient is checked in, data becomes available thatmakes up the patient visit report. There are two primary “views” of thevisit data from a reporting standpoint. The “Procedure Log” contains alldata collected during a visit. The “Procedure Report” contains thesections of the “Procedure Log” that are considered important to thepatient and clinical clients of the lab.

[0078] Until the procedure report has been approved by the assignedphysician, it is considered a preliminary report. At specific stagesduring the visit (and the life time of a report), a version of thisreport is sent to a system, e.g. ERIS system. A copy of the final reportis placed in the patient history folder. All data applying to a patientvisit is organized by sections to facilitate assembly and customizationof the procedure log and report. Examples of the a report sections mayinclude Demographics; Referring Diagnosis; Hemodynamics; DopplerMeasurements; Stress Parameters; and Wall Motion Graphics, etc.

[0079] The report module also allows default inclusion/exclusion andordering of data sections for multiple versions of the report. Reportversions may include Online procedure Log; Online procedure report;Printed procedure report; and ERIS procedure report, etc. The reportmodule also specifies ad hoc inclusion/exclusion of data sections for aspecific report version applied to a particular visit.

[0080] In a reporting process, typically a report signoff sequencerequires sonographer signoff prior to physician signoff. In the presentsystem, the physicians and sonographers may perform report signoffs fromremote locations via Web access. During an online report review,specific signoffs may be authorized and performed by required clinicianregardless of whether a current user logged into the system. In thereport module, customized versions of a preliminary or final report canbe sent to an electronic report system based on either specific datamodifications or specific patient visit status transitions or events.This allows efficient navigation to and from data sources from theonline report. Further, access to data element helps text andcalculation definition from the online report. Also, an immediatelyupdate report data based on changes to underlying visit data can begenerated.

[0081] Further, the report module may incorporate all graphic elementsof data, for example, wall motion graphics, thoracic aorta view, ondevices with a graphic display capability. The report may also providean alternate textual representation of graphically generated data, forexample, wall motion comments/scoring, to be used for output targetswithout a graphic display capability. The final reports may be faxed tooutreach or other remote locations. Any data modifications subsequent toa final report signoff may result in future reports indicating that thereport has been modified. Modified data may be optionally flagged in anonline report.

[0082] It is appreciated that an online report is optional, and that thereport can be a printed report. The module may use distinct, easily seengraphical cues online and printed reports to distinguish betweenpreliminary and final reports, and between original and modified finalreports.

[0083] 8) Serial Studies Module

[0084] Serial studies allow for the time-based analysis of particularmeasurements regarding a specific patient. They are typically used fortracking the progress and health of a particular patient. In contrast,research studies or protocols aggregate measurements from many patientsfor the purpose of statistical analysis.

[0085] Serial studies are identified and created by study type. Serialstudy types may include oncological and hypertensive types. Each patientmay only have one serial study of each type active at a given time.Additional serial study types can be created at any time. Serial studiesmay be initiated for a patient at any time. The incorporation of aparticular visit into an ongoing serial study may be at the discretionof the clinicians.

[0086] It is appreciated that in some instances, a particular visit maynot be flagged, as the visit is not applicable to a serial study so asnot to skew trend data or due to emergency procedures. By default, avisit may become a part of a serial study, but a user may override thedefault.

[0087] Once a measurement has been assigned to a particular study type,the module may prompt or otherwise aid the user in acquiring themeasurement in future studies. The serial studies module provides theability to review the measurements assigned to serial studies across allapplicable visits. Data are displayed in a convenient format, such as atabular format. Individual measurements should be selectable for graphicrepresentation and/or comparison over time. Serial studies may beincluded on a procedure log and/or a procedure report as desired.

[0088] 9) Research Protocols Module

[0089] Research protocols module provides retrospective statisticalanalysis of aggregated patient data to support the research andeducational needs of a practice and other organizations. Data forresearch protocols module may include measurements, demographics, and/orother subjective information. Research can be partitioned for clinicalinformation in order to accommodate rules of privacy.

[0090] Unique billing codes may be assigned to research protocols. Themodule may prompt or otherwise aid a user in identifying missingprotocol measurements since it may be preferred that all measurementsassigned to a protocol are collected during a protocol visit. It isappreciated that a visit may be scheduled in support of multipleprotocols. The data associated with a protocol are provided toresearchers by the research protocols module or any other modules in thesystem.

[0091] The module allows the creation of research protocol definitionsat any time and allows measurements to be assigned to researchprotocols. Also, the module accommodates the creation ofquestionnaire-style informational data items that can be quantified orstratified for research purposes.

[0092] 10) User Interface and Common Services Module

[0093] The user interface and common services module provides bothautomatic and user-initiated mechanism for storing data. The moduleprovides an “expert mode”support for rapid entry of data to familiarusers. The module thus allows efficient, intuitive navigation to allcomponents of a patient visit. It is appreciated that the automatic datastoring mechanism or user-initiated data storing mechanism can be anyknown type, such as the computer software wizards or templates, etc. Itis also appreciated that the user interface and common services modulecan be operated in the Internet environment.

[0094] 11) Web-based Module

[0095] The web-based module provides all application interface screensprimarily deployed within a web browser. The security feature isimplemented in the web-based module to restrict certain operationalinterface access, for example, measurement entry, scheduling, etc., tothe appropriate departmental or institutional personnel. The securityimplementation allows for viewing of a report, such as a patient's finalreport, by a variety of interested parties, especially referringphysicians. The security features can be configured in a separatemodule, such as a security and user configuration module (see laterdiscussion).

[0096] Accordingly, the system can be web-based. The system may beimplemented by using a combination of XML, dynamic HTML, static HTML,Java, or an Oracle database, etc. The technologies simplify deploymentby allowing the application to be deployed in a web browser. Forexample, by using Enterprise Java Beans, the system may generate an XMLreport that can be stored in a database allowing for easy access fromany electronic medical system.

[0097] In one exemplary implementation, the system may incorporate thefollowing applications:

[0098] At the server side technology:

[0099] Java and EJB (server-side component architecture, rapidapplication development, maintainability and extensibility),

[0100] Database and XML (dynamic document-oriented view of visit andmeasurements, portable data format, XML-to-relational mapping ofreports), or

[0101] Sun-Oracle-BEA's WebLogic (scaleable, reliable, secure);

[0102] At the client side technologies:

[0103] Java Applets (“List” oriented views, synchronization of data),

[0104] DHTML (patient-centered views, frame management, Javascript forlocal validation where appropriate), or

[0105] Sun-Oricle-BEA's WebLogic (track record, scaleable, reliable andsecure).

[0106] 12) Unique Reports Module

[0107] In addition to a procedure report, other reports may be generatedto aid in various phases of user operations. Some of these reports areautomatically generated based on specific system actions or visitstatuses. Others can be generated upon request. Also, the moduleidentifies which location or a remote location a report is sent to.

[0108] The module also provides a relational database with supportingviews to allow effective creation of predefined and ad hoc practicemanagement reports.

[0109] 13) Database Module

[0110] The database module stores all application data in a relationaldatabase for ad hoc query and statistical analysis access. It isappreciated that any known relational database can be used withoutdeparting from the scope of the present invention.

[0111] 14) System Administration Module

[0112] The system administration module configures a select list forselection fields/combo boxes not specifically populated from databasecontents or measurement configuration. It is appreciated that any knownsystem manager functions may be used within the scope of the presentinvention.

[0113] 15) Security and User Configuration Module

[0114] The security and user configuration module provides securityfunctions for the system both internally and externally. For example,the module identifies particular users to access particular fields ofthe system according to defined users' roles in the system.

[0115] For example, identified users' roles may include sonographer,physician, appointment secretary, desk secretary, technician, andadministrator, etc. It is appreciated that users may be added or deletedfrom a pre-defined user list. Accordingly, the module provides thecapability to restrict access to application screens by lab role andindividual user.

[0116] The implementation for the security access to the system can beany known mechanism, such as the traditional security access by login IDand password. The login ID and password mechanism can be separate ordistinct from other applications operated on a system. Further,workstation locations can be pre-defined by the system at login, anddefaults for initial screens, room coverage, and printer location can bepre-defined.

[0117] Medical information and patient privacy are heavily regulated inthe United States and in foreign countries. The security and userconfiguration module are preferably compliant with the current knownregimes of regulation in the country of implementation of the system,and are adaptable to meet new requirements and regulations as newregimes are enacted. In the U.S. at this time, the Health InformationPatient Privacy Act (HIPPA) is the principal regulatory structure. Thesecurity and user configuration module is preferably compliant with andadaptable to meet all current and future HIPPA requirements.

[0118] 16) Image Integration Module

[0119] The image integration module may be implemented in associationwith imaging systems, such as echocardiogram imaging systems, etc.Accordingly, the module is capable of adapting to the features and/orfunctions similar to the imaging systems. For example, the module storesimage data from a patient study, measurements, demographic, and/or otherrelevant data available, on electronic media, such as DICOM-enabledultrasound systems.

[0120] The image integration module also transfers demographicinformation from a lab system to another appropriate ultrasound devicevia DICOM prior to beginning of a study or when information is madeavailable. This allows rapid random access to the stored image data thatcorresponds to a study.

[0121] In addition, the image integration module provides an enhanceduser interface that includes measurement “tools” familiar to ultrasoundusers so that it allows measurements to be created or modifiedretrospectively.

[0122] Further, the image integration system may incorporate selectedimages and video segments into an online patient report at thediscretion of users. It is appreciated that restrictions on deliverytechnologies, such as printers and electronic record system, mayrestrict the selected images and video segments on certain formats.

[0123] In cases where a single measurement is made multiple times, auser can either select a single instance or have the module to averageselected values.

[0124] 17) System/Technical Support Module

[0125] The system/technical support module supports separate test,integration, and production environments, provides on-line access tomanuals covering user navigation and system overview, and/or provides aTechnical Engineering Document. It is appreciated that thesystem/technical support module may adhere to certain guidelines, suchas published system/technical user interface guidelines, a systemsadministrator guide, etc. Further, the module provides schedules forbackup and system maintenance activities.

[0126] The module further provides a robust, automatic distribution, andinstallation feature. This feature allows easy dissemination of updatedsoftware to client hardware. When a workstation first accesses thesystem, the system ascertains whether a more up-to-date version of thesoftware exists. If so, the system downloads and installs the up-to-dateversion before a user proceeds.

[0127] Furthermore, the module archives data based on user-specifiedaging parameters and provides a capability to retrieve archived data forquery. For example, the module supports a data capacity based on patientvisits for the number of patients in the first year, with the practicegrowing by a percentage per year thereafter. Another example is that themodule supports a minimum 3-year on-line data capacity based onperforming a number of procedures in the first year, with the practicegrowing by a percentage per year thereafter. A further example is thatthe module supports an installed base of 100 to 17,000 workstations,with 150 users logged on at a time, and allowing for 100 concurrent dataentry users.

[0128] In one implementation, the system runs on WINDOW NT 4.0 with 32Mof RAM, 133 to 300 Megahertz CPUs.

[0129] For enhanced system performance, activities taking place in thepatient's presence are prioritized higher than administrative reportingactivities. The module displays a warning when concurrent updates areattempted. Within each major task of a patient visit, the moduleexpedites the processing of screens so as not to impede progress. Themodule is optimized for response time performance, once a patient hasbeen selected and once task has been initiated.

[0130] In one implementation, the module supports maximum systemresponse times of less than two seconds when moving between patientstates, or when switching to a patient visit from history that is notcached. During a patient visit (either a current one or a past visitwhich has been loaded to cache), responses from a server to a client arewithin one half second. For all responses that rely on externalinterfaces, the response time is preferably less than two seconds. It isappreciated that other response time can be implemented within the scopeof the invention.

[0131] 18) Knowledge Base Module

[0132] In one implementation, the knowledge base can provide informationto users of the system and clinicians as which tests should be performedor which measurements should be collected for a given initial diagnosis.Valid ranges for measurements or outcomes for particular procedures areprovided to clinicians and technicians carrying out the test andmeasurements to ensure that valid data are collected. Once initial datahas been collected during a patient visit, the knowledge base canprovide the clinician feedback regarding the initial diagnosis andwhether the data collected appears to support that diagnosis. If thedata appear to suggest a different diagnosis, the knowledge base canprompt the clinician to perform additional measurements and gatheradditional information that may further confirm the initial diagnosis orpoint to a new diagnosis.

[0133] The knowledge base module may be developed from the collectivebackground knowledge of the ultrasound laboratory derived from manyyears of operation. Statistical and other historical analysis of dataand diagnosis of prior patient outcomes, in combination with theknowledge and expertise of current clinicians contribute to theknowledge base. As new ultrasound tools and techniques are incorporatedinto laboratory operations, initial assumptions as to appropriate validmeasurement ranges are included in the knowledge base and verifiedagainst the actual measurements observed during clinical usage. Further,the initial and revised diagnoses supported by particular measurementsderived from such new tools and techniques are also incorporated intothe knowledge base. As more experience with the new tools and techniquesare gained through clinical use, these initial assumptions may be testedagainst actual patient outcomes to revise and refine the contents of theknowledge base.

[0134] In another implementation of the knowledge base, the knowledgebase incorporates a universal glossary related to the operation of anultrasound laboratory. By supplying all users of the laboratoryinformation management system with a common taxonomy, more uniform andconsistent data regarding diagnoses, measurements and outcomes can bepromoted, which will in turn allow the knowledge base to be maintained,improved and extended. To permit and promote this on-going improvementand extension of the knowledge base, users of the laboratory informationmanagement system may be required to agree to use of the common glossarywhen taking and compiling measurements.

[0135] Referring now to FIGS. 1 through 4, a sample operationalenvironment for an ultrasound laboratory information management system100 is illustrated. System 100 includes a central office or laboratoryinstallation 102, and two remote laboratory installations 104 and 106.Installation 102 includes a module server 108 with an attached database110, a knowledge base server 112 with an attached database 114, at leastone client intake system 118 and multiple ultrasound devices 120, 122,and 124. Also included in installation 102 is a communications gateway117. These elements which comprise installation 102 are linked by alocal area network or LAN 134. It is anticipated that more ultrasounddevices may be included in installation 102. In addition to ultrasounddevices, other laboratory analysis tools may be incorporated intoinstallation 102 and linked to the other elements of installation 102via LAN 134. Module server 108 may include multiple physical servers ora single high-throughput server. Databases 110 and 114 can be logicalpartitions of a single database server or may be physically distinctdatabase servers. In addition, each of the database servers 110 and 112may include multiple physical servers. The size and number of hardwaredevices included in central laboratory installation 102 will depend onthe size and overall complexity of installation 102, the number of userssupported by installation 102, the number of ultrasound devices 120, 122and 124 included in installation 102 and the capabilities of thehardware and software which comprise the installation.

[0136] Remote laboratory installations 104 and 106 are similarlyconfigured to installation 102. It is anticipated that remoteinstallations 104 and 106 will be smaller and support fewer users thaninstallation 102. However, a remote installation 104 or 106 may actuallybe larger or more complex than installation 102. It is also anticipatedthat more or fewer remote installations may be incorporated into system100.

[0137] Remote installation 104 includes a client intake system 118, anumber of ultrasound devices 126 and 128 and a LAN 134. Remoteinstallation 104 also includes a communication gateway 117 which islinked with communications gateway 117 of installation 102 via a wiredconnection 115, such as an intranet, the Internet, a leased line or acombination thereof. Remote installation 104 may also include a localserver 136 and local database 138 to capture and maintain data frompatients seen at remote installation 104 which is only of interest tolaboratory staff at remote location 104.

[0138] Remote installation 106 includes a client intake system 118, anumber of ultrasound devices 130 and 132 and a LAN 134. Remoteinstallation 106 also includes a communication gateway 117 which islinked with communications gateway 117 of installation 102 via aconnection 116 which includes a wireless communication element such assatellite networking, cellular technology or radio communication. Remoteinstallation 106 may also include a local server 136 and local database138 to capture and maintain data from patients seen at remoteinstallation 104 which is only of interest to laboratory staff at remotelocation 106.

[0139] It is anticipated that more ultrasound devices may be included inremote installations 104 and 106. In addition to ultrasound devices,other laboratory analysis tools may be incorporated into remoteinstallations 104 and 106 and linked to the other elements of remoteinstallations 104 and 106 via LANs 134.

[0140] Referring now to FIG. 5, an overall table layout 200 whichsupports the integrated laboratory information management system isshown. FIG. 5 indicates the individual grids into which table layout 200has been broken down into and indicates which of the following FIGS. 5Athrough 5X includes a more detailed view of data tables and datalinkages within the grids.

[0141] Referring now to FIG. 5A, an exemplary table 202 within tablelayout 200 includes a table title 204, a table header 208, and tabledata 206. Table header 208 and table data 206 may include one or aplurality of data elements 210, and some data elements 210 may bedesignated primary or secondary indexing keys. In the interest ofclarity, each table 202 within table layout 200 has not been labeled butis understood to include the same structure described above.

[0142] Between tables within table layout 200 are a plurality of tablelinkages 212, indicated by both dashed and solid lines, which mayinclude end symbols 214 including diamonds and circles, some of whichare labeled on FIG. 5A. In the interest of clarity, each table linkage212 and end symbol 214 within table layout 200 has not been labeled butis understood to indicate a logical link defined between data elements210 inside the tables. The various lines 212 and end symbols 214indicate the nature of the relationship between data tables 202connected by lines 212.

[0143] The foregoing description of the exemplary embodiment of theinvention has been presented for the purposes of illustration anddescription. It is not intended to be exhaustive or to limit theinvention to the precise form disclosed. Many modifications andvariations are possible in light of the above teaching. It is intendedthat the scope of the invention be limited not with this detaileddescription, but rather by the claims appended hereto.

What is claimed is as follows:
 1. A laboratory information managementsystem comprising: a plurality of linked modules which perform thefollowing functions: tracking patient status from initial appointmentscheduling to discharge from the laboratory following appointment;capturing demographics information regarding the patient; capturinginformation regarding patient treatment during the appointment for thegeneration of a bill for the treatment provided; indicating a set ofsuggested procedures to be performed during the appointment based on areferral diagnosis for the patient; capturing information regardingmeasurements taken or derived during the appointment; capturingmeasurement information and image data generated during the appointment;capturing final impressions and interpretations of laboratory staffregarding the procedures performed and the measurements derived duringthe appointment; generating a plurality of standard reports based on theprocedures preformed during the appointment, the standard reportsincorporating measurement information and image data captured during theappointment; verifying if patient has been assigned to a serial studyand prompt for laboratory staff to perform additional proceduresrequired for the serial study if not the necessary information and imagedata have not been captured during the appointment; assigninginformation and image data collected regarding the patient during anappointment to a research protocol if the patient has been assigned tothe research protocol; a user interface for system users and laboratorystaff interaction with the modules including required anduser-customizable elements derived from at least one of the modules;creating ad hoc reports which incorporate information and image datacaptured or derived during the appointment, referral diagnoses, andlaboratory staff impressions and interpretations; configuring user inputfields, which may include specification of the nature of information tobe entered into the fields and a list of allowable field entries;configuring and administering access privileges for system users basedon an assigned role of the user and security of patient clinical andresearch data; provide separate development, testing, integration andproduction environments, and provide on-line access to user manuals andtechnical documentation regarding the environments and modules to systemusers; storing and indexing patient information, information capturedduring the appointment and other reports generated from the patientinformation and the information captured during the appointment in arelational database linked to the plurality of modules.
 2. Thelaboratory information management system of claim 1, wherein thelaboratory is a medical ultrasound laboratory.
 3. The laboratoryinformation management system of claim 1, wherein the user interface isdelivered to a web browser and users and laboratory staff interact withthe modules through the web browser.
 4. The laboratory informationmanagement system of claim 2, wherein the image data for the patientcaptured during the appointment is indexed and stored in a separateimaging database, and imaging data stored within the imaging database islinked to the information regarding the patient.
 5. The laboratoryinformation management system of claim 2, wherein the modules are linkedto a knowledge base which provides suggested measurements and analysistechniques for a given proposed diagnosis, normal value ranges formeasurements taken during a patient visit, and a suggested diagnosis fora given set of patient measurements and observations.
 6. The laboratoryinformation management system of claim 5, wherein the knowledge base isderived from historical diagnosis, measurement and medical outcomesinformation collected.
 7. The laboratory information management systemof claim 6, wherein the knowledge base allows measurements outside thenormal value ranges to be entered into the patient record uponvalidation by an approved operator.
 8. The laboratory informationmanagement system of claim 7, wherein measurements included in thepatient's record during an appointment may be flagged for further reviewand analysis.
 9. The laboratory information management system of claim2, wherein the security tool is fully compliant with health informationprivacy protection standards.
 10. The laboratory information managementsystem of claim 2, wherein the modules are accessible by a remote user.11. The laboratory information management system of claim 10, whereinthe remote user accesses the modules via a wired link.
 12. Thelaboratory information management system of claim 10, wherein the remoteuser accesses the modules via a wireless link.
 13. The laboratoryinformation management system of claim 2, wherein the modules aredeveloped utilizing at least one non-proprietary open source developmentenvironment.
 14. A method of managing information within an ultrasoundimaging medical laboratory comprising the steps of: providing alaboratory information management system including a plurality of linkedmodules; tracking patient status from initial appointment scheduling todischarge from the laboratory following an appointment; capturingdemographics information regarding the patient; capturing informationregarding patient treatment during the appointment for the generation ofa bill for the treatment provided; indicating a set of suggestedprocedures to be performed during the appointment based on a referraldiagnosis for the patient and; capturing information regardingmeasurements taken or derived during the appointment; capturing finalimpressions and interpretations of laboratory staff regarding theprocedures performed and the measurements derived during theappointment; capturing measurement data generated during the proceduresand provide this data to a report generation tool; verifying if patienthas been assigned to a serial study and prompting for any additionalmeasurement data required for the serial study if these measurement datahave not been captured during the procedures; assigning data collectedregarding the patient during the appointment to a research protocol;delivering a user interface to a web browser, the user interfaceincluding required and user-customizable elements derived from othermodules; limiting access privileges for system users and laboratorystaff based on an assigned role of the users and staff; receiving,indexing, and storing imaging information captured during theappointment, and providing a linkage between the patient's records andimaging information related to that patient; utilizing a relationaldatabase for the storage, organization and retrieval of the patient'sinformation including data and imaging information captured or derivedduring the appointment.
 15. The method of claim 14, wherein the methodfurther includes the step of providing laboratory staff with a knowledgebase, the knowledge base suggesting measurements to be taken during theappointment based on the referral diagnosis, and valid ranges formeasurements taken during the appointment based on patient demographicinformation and other physical characteristics of the patient.
 16. Themethod of claim 15, wherein the system includes an ad hoc reportgenerating tool and the method further includes the creation of ad hocreports which may incorporate data and image information captured orderived during the appointment, including the referral diagnoses, andany laboratory staff impressions and interpretations.
 17. Amultifunctional, integrated ultrasound laboratory information managementsystem of claim comprising: a business management part of the integratedsystem manages all aspects of the operation of a ultrasound laboratory,and includes documenting exam encounters, demographics, accounting,scheduling, billing, productivity measures, clinical accountability, andis linked to external systems for functions including third partybilling, coding, documentation, and reimbursement; a ultrasound datamanagement part includes acquisition, collation, and reporting ofacquired alphanumeric information, such as measurements, hemodynamics,function, flow calculations, derived information, impressions, textdescriptors, derived from clinical ultrasound examinations, and supportsthe presentation of data in tabular, textural, graphic, or pictorialformats, and the content and structure of the ultrasound data managementpart adaptable to accommodate new data types and formats, the ultrasounddata management part further supporting the designation of particulardata for education, research, treatment, and therapeutics; a ultrasoundimage data management part accommodates large-sized documents, such asgraphics, still and cinematic pictures, digital documents, parametricinformation, and permits retrieval and display of the image data at highlevels of graphics density and at a high frame rate.
 18. Themultifunctional, integrated ultrasound laboratory information managementsystem of claim 17, wherein the information managed by the businessmanagement part, the ultrasound data management part, and the ultrasoundimage management part are integrated into a single informationmanagement system.
 19. The multifunctional, integrated ultrasoundlaboratory information management system of claim 18, wherein theintegrated system is built from a plurality of modular components, whichcan be removed, modified, and/or replaced as desired, and wherein theintegrated system is extensible and supports multiple data and graphicformats, and image management technologies.
 20. The multifunctional,integrated ultrasound laboratory information management system of claim17, wherein the integrated system is for use by a medical cardiovascularultrasound imaging and hemodynamic laboratory.
 21. The multifunctional,integrated ultrasound laboratory information management system of claim17, wherein the parts of the integrated system include a plurality ofintegrated modules, each of the modules being interfaced via arelational database.
 22. The multifunctional, integrated ultrasoundlaboratory information management system of claim 21, wherein theinformation managed by the parts of the integrated system, includingacquired information, reported information, and administrationfunctions, may be accessed via web-based protocols, and the integratedsystem is hosted on industry standard hardware and software platforms.23. The multifunction, integrated ultrasound laboratory informationmanagement system of claim 22, wherein one of the plurality of modulesincludes a logic program which flags missing data during a clinicalultrasound procedure and informs a user if the objectives of theprocedure have been met.
 24. The multifunction, integrated ultrasoundlaboratory information management system of claim 22, wherein one of theplurality of modules includes a comprehensive ultrasound relatedrepository of source material, such as medical literature validation ofmeasurements, calculations, source information, vocabulary anddefinitions.
 25. The multifunction, integrated ultrasound laboratoryinformation management system of claim 22, wherein one of the pluralityof modules is a serial study module supporting tabular and graphicpresentations of data, including sequential data from a single encounteror from multiple encounters, and allows the collation of these data intoa tabular or graphic report.
 26. The multifunction, integratedultrasound laboratory information management system of claim 22, whereinone of the plurality of modules is a security module includingcommunication algorithms to maintain user and client security when theintegrated system is accessed through local or extended networks linkedto the integrated system.
 27. An ultrasound laboratory informationmanagement system comprising: a comprehensive ultrasound relatedrepository of source material, such as medical literature validation ofmeasurements, calculations, source information, vocabulary anddefinitions, and a logic program which flags missing and out-of-rangemeasurement data during a clinical ultrasound procedure and informs auser if the objectives of the procedure have been met.
 28. An ultrasoundlaboratory information management system comprising: a securityapplication including communication algorithms to maintain user andclient security when the integrated system is accessed by a local or aremote user linked to the integrated system which maintains privacy ofpatient health information in compliance with governmental regulations.29. An ultrasound laboratory information management system comprising:an application permitting the system to be accessible by a remote userutilizing a web browser.